替比夫定与恩替卡韦治疗高病毒载量e抗原阳性乙型肝炎的疗效比较

Comparison of telbivudine and entecavir in treatment of hepatitis B virus e antigen-positive chronic hepatitis B patients with high viral load

目的比较替比夫定（LdT）与恩替卡韦（ETV）治疗HBeAg阳性慢性乙型肝炎（CHB）伴高病毒载量（HBVDNA≥10^7拷贝，mL）患者144周的临床结果。方法将81例HBeAg阳性CHB伴高病毒载量的患者随机分成2组，LdT治疗41例，ETV治疗40例；连续观察144周。比较治疗的相同时间点两组患者的疗效，包括HBVDNA水平、HBV血清标志物、生化学指标、相关并发症、病毒耐药及治疗费用情况。结果两治疗组基线特征具有可比性。第4、8、12周HBVDNA转阴率，LdT组分别为24．4％、63．4％和80．5％，与ETV组比较差异均有统计学意义（X^2=5．102，P〈0．05），但至144周时两组比较差异无统计学意义（97．6％：100．0％，X^2=3．374，P〉0．05）。治疗144周后，LdT组的HBeAg血清转换率为63．4％，高于ETV组的25．0％，经Kaplan—Meier法检验差异有统计学意义（X^2=12．183，P〈0．01）。LdT治疗2例（4．9％）发生HBsAg血清转换，5例（12．2％）发生耐药，8例（19．5％）肌酸激酶（CK）升高；而ETV治疗无耐药及CK升高发生。LdT治疗费用较ETV低。结论高病毒载量HBeAg阳性CHB者，经LdT或ETV治疗144周均获得满意的病毒抑制率。ETV低耐药、无不良反应；LdT获得较高的早期病毒抑制，血清转换率高，费用低。

Objective To compare the efficacy of telbivudine（LdT） and entecavir （ETV） in treatment of hepatitis B virus e antigen （HBeAg）-positive chronic hepatitis B （CHB） patients with high viral load （HBV DNA ≥10^7copies/mL）. Methods Eighty-one HBeAg-positive CHB patients with high viral load were divided into LdT group （n=41） and ETV group （n=40）. All patients received a 144-consecutive-week treatment. HBV DNA level, HBV serological markers, biochemical index, related complications, and drug resistance were observed and compared at the same time points between two groups. Results Baseline data of two groups were comparable. At 4, 8 and 12 weeks, HBV DNA negative rates of LdT group were 24.4%, 63.4% and 80.5%, higher than 12.5%, 27.5% and 70.0% of ETV group with significant differences （X^2=5.102, P〈0.05）; but no significant difference in HBV DNA negative rates at 144 weeks was noted between two groups （97.6% vs 100.0%,X^2=3.374, P〉0.05）. After 144-week treatment, HBeAg seroconversion rate of LdT group was 63.4%, higher than 25.0% of ETV group with a significant difference （X^2=12.183, P〈0.01）. In LdT group, 2 cases （4.9%） had HBsAg seroconversion, 5 cases （12.2%） developed drug resistance, and 8 cases （19.5%） had an elevation of creatine kinase. The total cost of LdT treatment was lower than that of ETV. Conclusions HBeAg-positive CHB patients with high viral load can obtain complete viral suppression after long-term （144 weeks） treatment with LdT or ETV. ETV has the advantage of low drug resistance and no adverse reaction, while LdT has higher rate of early viral suppression and seroconversion, and low cost.